2022-12-05T00:22:00+00:00By Francesca Buttigieg
Greg Perry, Assistant Director General, discussed in this year’s annual lecture, learnings on the IFPMA and the impact of the COVID-19 pandemic on Africa. In particular, the importance of building a strong infrastructure within the continent, in relation to the establishment of the AMA.
2022-12-05T00:21:00+00:00By Frederic Pailloux
The session gave some insight on the Accelerating Clinical Trials in the EU (ACT EU) and the EMA Q&As on CCTs, a guidance regarding scientific aspects and the planning, set-up and submission for CTA applications, as well as conduct, reporting, analysis and interpretation of CCTs.
2022-12-05T00:20:00+00:00By Segolene Saintpierre
Expedited programmes available in the US, Europe and UK all aim to streamline process and ensure early access of medicinal products to patients; however, they are not yet fully delivering on their promises.
2022-12-05T00:19:00+00:00By Sobhey Nassar
The profession needs to adapt to the power of technology and the widespread dissemination of misinformation on social media is causing real-world harm.
2022-12-05T00:18:00+00:00By Claire Levee
This session focused on the evolution of the European Medicines Agency (EMA) and The European Network for Health Technology Assessment (EUnetHTA) collaboration.
2022-12-05T00:17:00+00:00By Celia Cruz
There are still many unanswered questions due to the silos between medicines and medical devices and there is a need for interdisciplinary cooperation – stakeholders with different skills – to optimally position Europe for innovation.
2022-12-05T00:16:00+00:00By Segolene Saintpierre
There is a global evolution in drug development and RWE policy, increasing contribution of RWD/RWE to clinical evidence generation.
2022-12-05T00:15:00+00:00By Sarah Heraghty
This session focused on patient engagement from different stakeholder perspectives.
2022-12-05T00:14:00+00:00By Nathalie Bourrit
Gene therapies are highly innovative products which have been approved only for the treatment of rare diseases so far. Changes in manufacturing processes during development as well as difficulties in gathering large clinical data sets explain the common challenges encountered by gene therapy developers to demonstrate the benefit of their ATMP.
2022-12-05T00:13:00+00:00By Francesca Buttigieg
Following last year’s success, Daniela Drago, Carlos Langezaal and Fortunato Fred Senatore were back to conduct another interactive session. Attendees gathered into groups to discuss and propose regulatory strategies based on a number of scenarios, three of which will be described here.
2022-12-05T00:05:00+00:00By Rhona Banks
The requirements for quality data for LM products have increased under the new Regulation. It is difficult to determine which regulatory framework is most appropriate for novel ATMs.
2022-12-05T00:04:00+00:00By Mel Munro
The new EU Veterinary Medicines Regulation contains specific provision for novel therapies. Established methodologies for demonstrating quality, safety and efficacy of veterinary medicinal products often cannot be applied to novel therapies.
2022-12-05T00:03:00+00:00By Beate Lohr
The Veterinary Regulation 2019/6 established new provisions and obligations for antimicrobials in veterinary medicines. Work on implementing regulations and guidelines is ongoing to further specify their use and restrictions.
2022-12-05T00:02:00+00:00By Kornelia Grein
Industry is navigating through complex new rules and opportunities for variations and will require continued cooperation. The year 2023 is expected to show the benefits of the revised pharmacovigilance procedures in practice.
2022-12-05T00:01:00+00:00By Pascale Canning
The secondary legislation and guidelines are as critical as Regulation 2019/6 itself in defining the future landscape for animal health in the EU. The concept and definitions of benefit-risk affect many different aspects of veterinary medicines regulation, as per the legislation.
2022-12-05T00:09:00+00:00By Mehryar Behizad
Cybersecurity is important for medical devices – those designed before the era of cybersecurity are most vulnerable to malware attacks and industry are searching for solutions.
2022-12-05T00:08:00+00:00By Mehryar Behizad
There is a variety of devices currently used to collect PROs and the data gathered in relation to orthopaedic surgery. The forthcoming AI, cyber resilience, data governance, and digital market acts are proposed as the regulatory landscape of the future.
2022-12-05T00:07:00+00:00By Michael Kipping
When developing novel products, small companies and start-ups must understand the regulatory pathways to market. NBs are providing support to industry in its transition to the EU Medical Device Regulation, but NBs are in high demand.
2022-12-05T00:06:00+00:00By Mehryar Behizad
EUDAMED is an integral part of the MDR and the actors, UDI and certificate modules are now live. The full effect of EUDAMED will not be realised until it is fully functional – all actors should accelerate their preparation for EUDAMED and upload information as soon as modules go live.
2022-12-05T00:12:00+00:00By Esteban Herrero-Martinez
This session focused on the implementation of the IVDR which went live on 26 May 2022.
2022-12-05T00:11:00+00:00By Esteban Herrero-Martinez
We are in a transition phase until EUDAMED is fully functional. Local Agency procedures must still be followed despite the IVDR go-live – this is administratively challenging.
2022-12-05T00:10:00+00:00By Celia Cruz
When developing novel products, small companies and start-ups must understand the regulatory pathways to market. NBs are providing support to industry in its transition to the EU Medical Device Regulation, but NBs are in high demand.
The peer-reviewed journal, published 11 times per year and available free to TOPRA members.
The Organisation for Professionals in Regulatory Affairs
TOPRA office
TOPRA Publishing, 6th Floor, 3 Harbour Exchange, South Quay, London E14 9GE, UK
Tel: +44 (0) 20 7510 2560
Email: publications@topra.org
TOPRA AISBL
Blvd du Souverain 280, 1160 Brussels, Belgium
Tel: +32 (0) 2 808 72 70
Site powered by Webvision Cloud